FDA: Cook beacon tip angio cath recall is Class I

The FDA labeled the recall of a select number of Cook Medical beacon tip angiographic catheters as a Class I, according to a filing published today.

A Class I label from the FDA indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

Cook has received 26 complaints and there have been 14 medical device reports to date on the issue, according to the FDA and Cook.

The catheters are being recalled due to an issue with tip splitting or separation which can lead to the loss of device function and separation that “may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs,” according to Cook.

The FDA indicated that 38,895 units in the U.S. are being recalled. The recalled units were manufactured between May 9, 2013 and September 1, 2014, and distributed between June 6, 2013 and June 25, 2015, according to the agency.

The units and catalog numbers affected by the recall are: Beacon Tip Torcon NB Advantage Catheters – Catalog Prefix HNBR5; Beacon Tip Royal Flush Plus High-Flow Catheters – Catalog Prefix HNR4.0; Slip-Cath Beacon Tip Catheters – Catalog Prefix SCBR5.0.

Cook Medical has provided a full list.

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